Tuesday, January 19, 2010

Note; These are combined stories. The various websites are listed with each story.Dave

Tylenol recall: FDA slams company

By Parija Kavilanz, senior writerJanuary 15, 2010: 9:50 PM ET

http://money.cnn.com/2010/01/15/news/companies/over_the_counter_medicine_recall/NEW YORK (CNNMoney.com) -- The maker of several over-the-counter drugs, including Tylenol, Motrin and Benadryl, announced a broad-based recall of these and other drugs Friday after receiving complaints of an "unusual moldy, musty or mildew-like" odor.

The recall drew the FDA's wrath on Johnson and Johnson (JNJ, Fortune 500) for not reacting quickly to customer complaints and its failure to fix the problem. The company has struggled to resolve the issue since it was first reported in 2008.

"The company should have acted faster," Autor said. "All companies have a responsibility to ensure high quality, safety and effectiveness of their products and protect consumers."

McNeil-PPC, the Johnson and Johnson division that manufactured the recalled products, said it received a "small" number of complaints of "non-serious" stomach problems, including nausea, stomach pain, vomiting or diarrhea. However, it did not say when the complaints were received or how many.

These products are widely sold through a number of retail stores, including large chain drug stores, independent pharmacies and supermarkets.

Autor said the FDA has issued a warning letter to McNeil, saying the company has 15 days to report back on its efforts to address the problem and prevent future violations.

In a letter, the agency said it is "concerned" about Johnson & Johnson's response to the matter.

A warning letter from the FDA is a very serious thing, explained Ira Loss, senior health policy analyst with consulting firm Washington Analysis.

"A warning letter indicates that this is the last time that the company will get a heads-up from the agency," said Loss. "If things don't get fixed, then there are other ways for the agency to make its point."

The agency warned Johnson & Johnson that "failure to correct these violations may result in legal action, including seizure and injunction."

Further, the agency warned that it may "withhold approval of requests for export certificates or approval of pending new drug applications" that list one of the company's facilities as a manufacturer until the violations are resolved.

Loss said he would not be surprised if the FDA is setting out to make an example of McNeil to other companies.

Said Loss, "The FDA's been criticized for not being aggressive enough in the past. The goal ultimately is to make the industry police itself so that we don't end up with situations like this."

On Friday, the FDA said McNeil informed the agency that it had received 70 complaints and expanded its recall of over-the-counter drugs.

The company said the smell was caused by a chemical called "2,4,6-tribromoanisole (TBA)," which is applied to wooden pallets that are used to transport and store packaging materials.

McNeil said a small number of the recalled drugs were found to contain small traces of TBA, but did not provide details about whether it changed the chemical composition of the drugs.

The FDA said the pallets were traced to a plant in Puerto Rico, and the agency is looking into whether any other drugmakers also used pallets from this plant to transport their products.

History of problems fixing a funky odorThe agency said McNeil first received complaints of an odor in its products in early 2008, but the company did not "identify it as an issue" until September of that year.

"McNeil did not report the issue to us until a year later," Karen Hirshfield, acting branch chief of the FDA's Recalls and Shortages Branch, told reporters.

In November 2009, McNeil recalled five lots of its Tylenol Arthritis Pain 100 count with the EZ-open cap product due to reports of an unusual moldy, musty, or mildew-like odor that led to some cases of nausea, stomach pain, vomiting and diarrhea.

On Dec. 18, 2009, McNeil expanded that recall to include all available product lots of Tylenol Arthritis Pain caplet 100 count bottles with the red EZ-open cap.

A spokeswoman for McNeil said about 500 "lots" of the products are included in the latest recall, which covers the Americas, the United Arab Emirates and Fiji. However, the company did not specify the total number of individual units of each drug affected by the recall.

McNeil said consumers who purchased from the lots included in its recall should stop using the product and contact McNeil Consumer Health care for a refund or replacement. Lot numbers can be found on the side of the bottle.

Consumers can call 1-888-222-6036 or log on to www.mcneilproductrecall.com. The company said consumers with medical concerns should contact their health care provider.

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McNeil receives FDA warning letterBy Michael Johnsen

http://www.drugstorenews.com/story.aspx?id=128289&menuid=793

ROCKVILLE, Md. (Jan. 15) As a stark reminder that the Food and Drug Administration under the Obama administration will act decisively and publicly, the FDA held a press conference Friday morning announcing that the agency earlier that morning issued McNeil Consumer Healthcare a warning letter for “multiple violations of current good manufacturing practices.”

“We’re working with the FDA to respond to their concerns,” said McNeil Consumer spokeswoman Bonnie Jacobs. McNeil declined to comment further.

The warning letter comes on the same day that McNeil issued a voluntary recall of more than 500 lots of products, including several Tylenol products and other brand names like Motrin, Rolaids, Simply Sleep and St. Joseph’s Aspirin. The products were recalled because of a possible chemical contaminant in the packaging that caused non-serious adverse events, such as nausea, diarrhea and vomiting.

“The FDA recognizes that McNeil is taking more extensive steps today to deal with the problem, including recalling lots that have not been the subject of consumer complaints,” Deborah Autor, director of the Office of Compliance, Center for Drug Evaluation and Research at the FDA told reporters. “However, McNeil should have acted faster. McNeil, and all drug manufacturers, have a corporate responsibility to assure that their products are high quality, safe and effective. When problems arise with their products, they must be proactive, quick and thorough,” she said. “When something smells bad, literally or figuratively, companies must aggressively investigate and take all necessary actions to solve the problem,” Autor added, referencing an odor associated with the contaminated products.

The FDA reported that the first consumer complaints received by McNeil for this issue occurred in September 2008. “However, McNeil did not notify the FDA of these complaints until a year later in September 2009,” Autor said. “Since the FDA became aware of the situation, the agency has repeatedly urged McNeil to identify the source of the problem and its scope and to recall any affected product.”

Reports claim Johnson & Johnson knew of the contamination issue, which is linked to health issues in some consumers, since 2008 but neglected to fully disclose the problem to shareholders and the general public until today after pressure by federal regulators.

The U.S. Food and Drug Administration issued a Warning Letter to the company for failing to disclose in September 2009 contamination of the products by 2,4,6-tirbromoanisole (TBA), a chemical used as a fungicide, wood preservative and flame retardant. Johnson & Johnson has admitted that the effects of TBA on humans have not been heavily studied. Consumers using the TBA-affected products have reported nausea, vomiting, and diarrhea.

"We are surprised that a company that has been praised in the past for confronting a crisis with complete honesty and quick action has now chosen to hide the facts from the public and the regulators and hope the problems would disappear," said Hagens Berman partner Reed K. Kathrein. "We hope to get to the bottom of the story on behalf of the investors we represent."

The firm is interested in talking with those who have first-hand knowledge of the issue.

You can also follow news about this investigation at www.hbsslaw.com. HBSS will treat all information shared as confidential.

About Hagens Berman Sobol Shapiro

Hagens Berman Sobol Shapiro is a nationally recognized class-action and complex-litigation law firm based in Seattle with offices in San Francisco, Chicago, Boston, Los Angeles and Phoenix. Among recent successes, HBSS negotiated a $300 million settlement in the DRAM memory antitrust litigation, the largest antitrust settlement in U.S. history, recovered $340 million on behalf of Enron employees, and was part of the leadership team in the $3 billion Visa/MasterCard settlement. In pharmaceutical litigation, the firm's recent successes include a $350 million settlement with McKesson, more than $200 million with other parties in drug-pricing litigation, and a $150 million settlement regarding Lupron. HBSS represented Washington and 12 other states against the tobacco industry that resulted in the largest settlement in history. For a complete listing of HBSS cases, visit www.hbsslaw.com.